MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER 03 VALVE REPAIR

Model Number SGC0301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr). After the steerable guide catheter (sgc) crossed the inter-atrial septum, a clot was noted on the sgc. Attempt was made to aspirate the clot, but it was not successful. The anticoagulant, angiomax was administered to dissolve the clot, but after ten to 15 minutes, the clot did not dissolve. It was decided to abort the procedure and remove the sgc. After the sgc was removed, no clot was visible on the sgc, but it was seen in the patient's right atrium, near the septum. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.

• Brand Name: STEERABLE GUIDE CATHETER 03
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10445576
• MDR Text Key: 204170082
• Report Number: 2024168-2020-07043
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/07/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00507U139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/24/2020 Patient Sequence Number: 1